Description

Flupirtine Maleate Impurity C is a specified impurity used in the analytical profiling and quality control of the active pharmaceutical ingredient, Flupirtine Maleate. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in the development and validation of analytical methods, stability studies, and as a certified reference standard.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, GC, and other chromatographic methods.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for establishing specificity, accuracy, and detection limits in impurity profiling.
• Quality Control & Assurance (QC/QA): Used for routine batch testing to monitor and control impurity levels in Flupirtine Maleate API.
• Stability Studies: Employed to identify and quantify degradation products under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Used in synthetic chemistry research to understand impurity formation pathways and purification processes.

Basic Information

Product Name	Flupirtine Maleate Impurity C
CAS No.	1506942-35-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Flupirtine Impurity C; Flupirtine Maleate Related Compound C; Ethyl 2-amino-6-[(4-fluorobenzyl)amino]-3-pyridinecarboxylate maleate; 2-Amino-6-[(4-fluorobenzyl)amino]-3-pyridinecarboxylic acid ethyl ester maleate; Flupirtine EP Impurity C; Flupirtine Maleate Impurity 3; Flupirtine Maleate Impurity 4 (Check with supplier for specific nomenclature)
EINECS	Contact for details

Quality Control

Every batch of Flupirtine Maleate Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.